Marijuana-derived Meds Recommended for FDA Approval
A new treatment for epilepsy is one step closer to FDA approval.
On April 19, an expert panel from the FDA recommended that the agency approve the use of a cannabidiol, or CBD, medication known as Epidiolex for treating epilepsy related to Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS). This is a major breakthrough, as it’s the first such approval of a medication derived from marijuana.
“This announcement constitutes very good news for all patients affected by these two devastating types of epilepsy, as the therapeutic effects identified in the controlled trials against placebo were quite robust and are likely to result in significant improvement of the seizure disorder and quality of life of these children (and their family),” says Andres Kanner, M.D., director of the Comprehensive Epilepsy Center at the University of Miami Health System.
Research on CBD and epilepsy
The FDA panel recommendation is the culmination of years of promising research into the impact of CBD on epilepsy. One of the most recent was a 2018 study of 108 children with epilepsy. The children were divided to receive their standard anti-epilepsy medication (clobazam), or the medication along with CBD. Among the group who received CBD, almost 40 percent of the children experienced a 50 percent drop in their seizure rate, and 10 percent of that group became completely seizure-free. It was a significant breakthrough that many researchers believe is worthy of more study.
“It should be emphasized, however, that efficacy of this drug in these two forms of epilepsy does not necessarily imply efficacy in other forms of epilepsy,” says Dr. Kanner. “Studies to establish efficacy in other types of epilepsy (e.g., focal epilepsy) are underway in the US and other countries, and we will need to wait for the data of these studies to know objectively if the drug can yield the same degree (if any) of efficacy demonstrated in Lennox Gastaut and Dravet syndromes.”
The future of CBD as medicine
Medical marijuana has been a topic of interest for decades now, as a pain reliever, a stress reducer and a treatment for a variety of ailments. It’s the tetrahydrocannabinol, or THC, that tends to draw the most attention in marijuana as the psychoactive ingredient that produces the “high” that users experience. But another, lesser known chemical within marijuana, cannabidiol, or CBD, may show even more promise as a legitimate medical treatment.
There are still a number of hurdles to jump before it makes its way into the medical mainstream. For one, CBD still isn’t legal in many states. And in the states where it is legal, many products that claim to offer the benefits of CBD do not have the levels of cannabidiol that they claim.
In addition, CBD has also been linked to many adverse side effects. Anxiety, depression, nausea, vomiting, fatigue, dizziness, diarrhea and changes in appetite are just a few of the potential impacts that have been noted in studies.
“Patients and their families must not lose sight of the fact that CBDs, while being extracted from a plant, constitute a drug with potential adverse events and are not a replacement of anti-epileptic medications,” says Dr. Kanner.
If you have a condition that may be helped by the alternative medicine, such as epilepsy or chronic pain, it’s best to ask your doctor about the treatment. He or she can suggest a safe, legal option if it’s available for you, in a form and at a dose that you can trust.
Written by a UMiami Health News staff writer.